Tolerability Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAspargo Labs, Inc

About this trial

This is an open-label, randomized study evaluating the tolerability of two concentrations of liquid metformin formulations (100 mg/mL and 250 mg/mL) compared with standard immediate-release metformin tablets in healthy adult subjects. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.

Eligibility criteria

Qualifiers

Male or female adults 18 to 55 years of age, inclusive.

Disqualifiers

Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.

Trial design

Treatments tested in this trial

  • Liquid Metformin 100 mg/mL
  • Liquid Metformin 250 mg/mL
  • Standard Metformin Immediate-Release Tablet

Treatment groups

24 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators